Author of

• 18749

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  P3.07 - Poster Session with Presenters Present (ID 493)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Regional Aspects/Health Policy/Public Health
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18756

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    P3.07-007 - Compassionate Use Program for New Cancer Drugs in Israel - Shortcut for Reimbursement Approval (ID 4873)

    14:30 - 14:30  |  Author(s): I. Erlich
    • Abstract

    Background:
    Drug accessibility and reimbursement remains a major challenge across the globe. The Israeli Ministry of Health (MOH) approves drugs based on previous approval by the FDA and EMA-EU. Compassionate use programs (CPU) represent the use of a compound approved by the FDA/EMA-EU before its approval by local regulatory authorities. CPU provides accelerated access to novel compounds to patients otherwise unable to get the treatment.
    
    Methods:
    This is a retrospective analysis of 102 patients treated with nivolumab, osimertinib, or nintedanib within a CPU in a single tertiary Israeli cancer center. Basic patient demographics, different logistic treatment aspects and the time from FDA/EMA-EU approval to reimbursement approval for these compounds in Israel were analyzed.
    
    Results:
    We started Nintedanib program by July 2014 when the official MOH approval was 16 months later in Nov 2015. Osimertinib program was started a year before the official approval by MOH and was approved for reimbursement 4 months prior to drug registration. Nivolumab for Non-squamous was started 6 months before approval, while for Squamous the label was approved by MOH 2 months after starting the compassionate program. Reimbursement approval was received 6 months thereafter for nivolumab (Squamous NSCLC). Two out of the three drugs in the program were approved for reimbursement, one of them even before MOH registration. Figure 1
    
    
    
    Conclusion:
    Compassionate use programs allow access to new cancer drugs prior to their approval by the regulatory authorities, increases physicians' experience with novel compounds and may affect reimbursement approval.